Label: LAURA GELLER BEAUTY SUN KISSED COLOR LIP BALM TRIO BROAD SPECTRUM SPF 15 PINK - CORAL - BERRY- octisalate, avobenzone, octinoxate, octocrylene kit
-
Contains inactivated NDC Code(s)
NDC Code(s): 51389-122-03, 51389-123-01, 51389-124-01, 51389-125-01 - Packager: LAURA GELLER MAKE UP INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 26, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- LAURA GELLER BEAUTY SUN KISSED COLOR LIP BALM TRIO BROAD SPECTRUM SPF 15 Pink - Coral - Berry
- Active Ingredients
- WARNINGS
-
Directions
- Apply liberally 15 minutes before sun exposure.
- Use a water resistant sunscreen if swimming or sweating.
- Reapply at least every 2 hours.
- Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10 a.m. - 2 p.m.
- wear long-sleeved shirts, pants, hats and sunglasses.
- children under 6 months of age: Ask a doctor.
-
Inactive Ingredients
Berry: Caprylic/Capric Triglyceride, C12-15 Alkyl Benzoate, Polyethylene, Pentaerythrityl Tetraisostearate, Mica, Microcrystalline Wax, Helianthus Annuus (Sunflower) Seed Wax, Silica Silylate, Stearalkonium Bentonite, Dicalcium Phosphate, Tocopheryl Acetate, Propylene Carbonate, Ethyl Vanillin, Pentaerythrityl Tetra-Di-T-Butyl Hydroxyhydrocinnamate, 1,2-Hexanediol, Caprylyl Glycol, Mangifera Indica (Mango) Seed Butter, Ethylhexyl Cocoate, Cocos Nucifera (Coconut) Oil. May Contain: Titanium Dioxide, Red 7 Lake, Iron Oxides, Blue 1 Lake Coral, Pink: Caprylic/Capric Triglyceride, C12-15 Alkyl Benzoate, Polyethylene, Pentaerythrityl Tetraisostearate, Mica, Microcrystalline Wax, Helianthus Annuus (Sunflower) Seed Wax, Dicalcium Phosphate, Silica Silylate, Stearalkonium Bentonite,
Tocopheryl Acetate, Propylene Carbonate, Ethyl Vanillin, Pentaerythrityl Tetra-Di-T-Butyl Hydroxyhydrocinnamate, 1,2-Hexanediol, Caprylyl Glycol, Mangifera Indica (Mango) Seed Butter, Ethylhexyl Cocoate, Cocos Nucifera (Coconut) Oil. May Contain: Titanium Dioxide, Red 28 Lake, Red 6
- Other Information
- Questions or comments?
- LAURA GELLER BEAUTY SUN KISSED COLOR LIP BALM TRIO BROAD SPECTRUM SPF 15 Pink - Coral - Berry (51389-122-03)
-
INGREDIENTS AND APPEARANCE
LAURA GELLER BEAUTY SUN KISSED COLOR LIP BALM TRIO BROAD SPECTRUM SPF 15 PINK - CORAL - BERRY
octisalate, avobenzone, octinoxate, octocrylene kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51389-122 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51389-122-03 1 in 1 KIT; Type 1: Convenience Kit of Co-Package 12/09/2013 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 2.5 g Part 2 1 TUBE 2.5 g Part 3 1 TUBE 2.5 g Part 1 of 3 LAURA GELLER SUN KISSED LIP BALM BROAD SPECTRUM SPF 15 PINK
octisalate, avobenzone, octinoxate, octocrylene lipstickProduct Information Item Code (Source) NDC:51389-123 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.5 g in 100 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 1.5 g in 100 g Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F) MICA (UNII: V8A1AW0880) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PROPYLENE CARBONATE (UNII: 8D08K3S51E) ETHYL VANILLIN (UNII: YC9ST449YJ) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) CAPRYLYL GLYCOL (UNII: 00YIU5438U) MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2) ETHYLHEXYL COCOATE (UNII: I1MPW273QS) COCONUT OIL (UNII: Q9L0O73W7L) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 28 (UNII: 767IP0Y5NH) D&C RED NO. 6 (UNII: 481744AI4O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51389-123-01 1 in 1 PACKAGE 1 2.5 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 12/06/2013 Part 2 of 3 LAURA GELLER SUN KISSED LIP BALM BROAD SPECTRUM SPF 15 CORAL
octisalate, avobenzone, octinoxate, octocrylene lipstickProduct Information Item Code (Source) NDC:51389-124 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.5 g in 100 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 1.5 g in 100 g Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F) MICA (UNII: V8A1AW0880) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PROPYLENE CARBONATE (UNII: 8D08K3S51E) ETHYL VANILLIN (UNII: YC9ST449YJ) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) CAPRYLYL GLYCOL (UNII: 00YIU5438U) MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2) ETHYLHEXYL COCOATE (UNII: I1MPW273QS) COCONUT OIL (UNII: Q9L0O73W7L) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 28 (UNII: 767IP0Y5NH) D&C RED NO. 6 (UNII: 481744AI4O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51389-124-01 1 in 1 PACKAGE 1 2.5 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 12/06/2013 Part 3 of 3 LAURA GELLER SUN KISSED LIP BALM BROAD SPECTRUM SPF 15 BERRY
octisalate, avobenzone, octinoxate, octocrylene lipstickProduct Information Item Code (Source) NDC:51389-125 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.5 g in 100 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 1.5 g in 100 g Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F) MICA (UNII: V8A1AW0880) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PROPYLENE CARBONATE (UNII: 8D08K3S51E) ETHYL VANILLIN (UNII: YC9ST449YJ) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) CAPRYLYL GLYCOL (UNII: 00YIU5438U) MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2) ETHYLHEXYL COCOATE (UNII: I1MPW273QS) COCONUT OIL (UNII: Q9L0O73W7L) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 7 (UNII: ECW0LZ41X8) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51389-125-01 1 in 1 PACKAGE 1 2.5 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 12/06/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 12/09/2013 Labeler - LAURA GELLER MAKE UP INC. (199474524) Establishment Name Address ID/FEI Business Operations Gotha Cosmetics SRL 378071679 manufacture(51389-125, 51389-124, 51389-123, 51389-122)